Insurance risk manager Work, Jobs in Cambridge, Cam (with Salaries)

Quality Assurance Manager
Activinsights Ltd —Kimbolton
- Full-time
- Bachelor's degree
- Continuous improvement
- No degree
- Free parking
- Life insurance
Quick apply
12d
Compliance Technical Support Officer
Cambridgeshire County Council —Huntingdon District
- £41,958 - £44,822 a year
- Microsoft Office
- Databases
- Administrative experience
- Annual leave
- Employee discount
11d
Head of Programmes
Marshall Land Systems Ltd —Cambridge
- Full-time
- Hybrid work
- Microsoft Word
- Engineering
- Continuous improvement
Practice Auditor - fixed-term for two years
Cambridgeshire County Council —Huntingdon
- £34,434 - £36,363 a year
- Microsoft Office
- Analysis skills
- Communication skills
- Annual leave
- Employee discount
12d
Vendor Manager, Publishing Operations
Public Library of Science —Cambridge
- £50,000 - £83,000 a year
- Remote
- Travel
- Annual leave
Statutory Review Officer - Beds
Hertfordshire Constabulary —Huntingdon
- £39,276 a year
- Full-time
- Travel
- Annual leave
- Employee assistance programme
Project Manager – Water Sector
Stantec —Cambridge
- Project management
- Budgeting
- Annual leave
Project Engineer
Levidian Nanosystems Ltd —Cambridge
- £45,000 - £60,000 a year
- Full-time
- PMP
- Writing skills
- Engineering
- Health & wellbeing programme
- Flexitime
Quick apply
4d
Product Manager
OGT —Cambridge
- Data analysis skills
- Analysis skills
- Continuous improvement
- Employee discount
Quick apply
Marketing Analytics Manager – 12 month Fixed Term Contract
Redgate —Cambridge
- £55,000 - £70,000 a year
- Hybrid work
- Heavy lifting
- Data analysis skills
- Analysis skills
- Annual leave
Assistant Project Manager (Construction Projects / Client Side)
Imperial War Museums —Duxford
- £30,000 - £32,000 a year
- Microsoft Powerpoint
- Microsoft Outlook
- No degree
- Annual leave
- Employee assistance programme
10d
Legal Operations Engineer - 5 month FTC
Redgate —Cambridge
- £80,000 - £90,000 a year
- Hybrid work
- Heavy lifting
- Contracts
- SharePoint
- Annual leave
Statutory Review Officer - Beds
Bedfordshire Police —Huntingdon
- £39,276 a year
- Full-time
- Travel
- Annual leave
- Employee assistance programme
Project Manager / Employer's Agent
Airey Miller —Cambridge
- £45,000 - £50,000 a year
- Full-time
- Writing skills
- Organisational skills
- Contracts
Quick apply
6d
Events & Admin Lead
Cambridge Enterprise —Cambridge
- From £37,500 a year
- Hybrid work
- Organisational skills
- Work from home
12d
End Of Contract Associate
Automated Systems Group Limited —Ely
- Up to £35,000 a year
- Full-time
- Contracts
- In-person
- Negotiation
- Free parking
- Store discount
Quick apply
Application Engineer Manager
Northland Controls —Letchworth
- Full-time
- Computer Science
- Engineering
- Analysis skills
- Annual leave
- Life insurance
Quick apply
11d
Lead Gardener
ABMC Cambridge American Cemetery —Cambridge
- Up to £59,000 a year
- Maintenance
- English
- Supervising experience
- Life insurance
- Sick pay
Quick apply
11d
Engineering Manager
Envar Composting —Huntingdon
- Full-time
- Management
- Engineering
- Continuous improvement
- Employee assistance programme
- Life insurance
Construction Planner
Stonbury Limited —Chawston
- Up to £70,000 a year
- Full-time
- Hybrid work
- Analysis skills
- Travel
- Communication skills
- Annual leave
13d

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Quality Assurance Manager

Activinsights Ltd
Kimbolton

Quick apply

Job details

Full-time | Fixed term contract
12 days ago

Benefits

Free parking
Company pension
Company events
Private medical insurance
Life insurance
On-site parking

Qualifications

Document control
Non-conformance investigation
Quality management change control procedures
Internal quality management system auditing
Compliance audits
Complaint handling
Quality assurance
Bachelor's degree
Continuous improvement
Continuous improvement cycles oversight
Risk management
ISO 27001
Supplier quality management
Supply chain quality assurance
Root cause analysis
Quality management system (QMS) implementation
Internal quality assurance
ISO 13485
Corporate regulatory compliance oversight
FDA regulations

Full job description

Role Purpose

The Quality Manager leads the effective operation, maintenance and continual improvement of ActivInsights’ Quality Management System (QMS), ensuring that products, services and business processes meet applicable regulatory, quality and customer requirements.

Reporting to the Regulatory Affairs Manager, the role owns the day-to-day management of the QMS and provides quality leadership across the business. The Quality Manager escalates significant quality and compliance risks and supports regulatory strategy, technical documentation, inspections and certification activities while maintaining clear accountability between Quality and Regulatory Affairs.

Responsibilities

QMS Leadership & Governance

Lead the operation, maintenance and continual improvement of the QMS in accordance with ISO 13485:2016, the FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, and other applicable requirements.
Coordinate management review, prepare QMS performance information and analyse quality metrics, trends and risks to support effective decision-making.
Support the continued development and effective use of the electronic Quality Management System (eQMS).
Monitor relevant quality standards and regulatory developments, working with the Regulatory Affairs Manager to assess and implement required changes.

Non-conformances, CAPA & Complaints

Manage non-conformances, corrective and preventive actions (CAPA), audit findings and root-cause investigations, ensuring actions are proportionate, effective and completed within agreed timescales.
Analyse quality issues and performance data to identify trends, reduce recurrence and drive continual improvement.
Support complain handling and post-market quality activities, ensuring significant issues are escalated and regulatory reporting requirements are considered with Regulatory Affairs.
Maintain effective change-control, document-control and record-control processes.

Audits & Supplier Quality

Plan and conduct the internal audit programme and host external certification, customer and regulatory audits or inspections.
Coordinate timely responses to audit and inspection findings and monitor resulting actions through to effective closure.
Manage supplier quality activities, including qualification, monitoring, audits and supplier non-conformances, in collaboration with relevant operational teams.

Product, Process & Risk Management

Ensure applicable cGMP requirements and quality procedures are implemented and maintained throughout the business.
Provide quality input into design and development, verification and validation, risk management, product or service changes and technical documentation.
Support the application of medical-device risk-management principles, including ISO 14971 where applicable.
Coordinate quality training and monitor completion and effectiveness of required QMS training.

Collaboration & Quality Support

Work with the Regulatory Affairs Manager to define and implement the quality strategy and provide quality support for regulatory compliance activities.
Support customers during vendor audits, respond to quality queries, demonstrate compliance and help manage complaints.
Work with operational and development teams to ensure the QMS is understood, implemented and maintained and that new or changed products and services are appropriately verified and validated.
Support information security management activities, including ISO/IEC 27001 requirements, where these interface with the QMS.
Undertake other reasonable duties and general office activities appropriate to a small and growing team.

You will work with:

Regulatory Affairs Manager

Senior Leadership Team

Development and Product teams

Manufacturing, Operations and Logistics

Commercial and Data Services teams

Employees across the wider business

Suppliers and other external service providers

Certification bodies, auditors and regulatory authorities

Candidate Attributes

· Relevant degree, professional qualification or equivalent practical experience in medical-device quality management.

· Significant experience managing or leading quality assurance activities within a regulated medical-device environment.

· Strong working knowledge of ISO 13485:2016 and the FDA Quality Management System Regulation (QMSR), 21 CFR Part 820.

· Practical experience of QMS management, CAPA, non-conformance investigations, root-cause analysis, internal and external audits, document control and quality metrics.

· Ability to work autonomously, prioritise effectively and make sound, evidence-based judgements while escalating material risks appropriately.

Skills & Behaviours

· Methodical and analytical, with strong attention to detail and a practical approach to problem-solving and continual improvement.

· Clear and confident written and verbal communicator, able to explain quality requirements and work collaboratively across the business.

· Able to influence constructively, maintain professional judgement and meet agreed targets and timescales.

Desirable Experience & Knowledge

· Experience within the electronics, engineered-device or connected-health sectors.

· Knowledge of ISO 14971 medical-device risk management and experience supporting design, verification and validation activities.

· Experience implementing, administering or improving an eQMS.

· Experience of information security management systems, including ISO/IEC 27001:2022.

Benefits:

Company events
Company pension
Free parking
Life insurance
On-site parking
Private medical insurance

Ability to commute/relocate:

Kimbolton PE28 0LF: reliably commute or plan to relocate before starting work (preferred)

Application question(s):

Do you have excellent knowledge of ISO13485 and 21 CFR 820

Education:

Bachelor's (preferred)

Experience:

medical device quality management: 3 years (required)

Work authorisation:

United Kingdom (required)

Work Location: In person

Quick apply

Refine Your Search

insurance risk manager jobs in cambridge, cam

Quality Assurance Manager

Compliance Technical Support Officer

Head of Programmes

Practice Auditor - fixed-term for two years

Vendor Manager, Publishing Operations

Statutory Review Officer - Beds

Project Manager – Water Sector

Project Engineer

Product Manager

Marketing Analytics Manager – 12 month Fixed Term Contract

Assistant Project Manager (Construction Projects / Client Side)

Legal Operations Engineer - 5 month FTC

Statutory Review Officer - Beds

Project Manager / Employer's Agent

Events & Admin Lead

End Of Contract Associate

Application Engineer Manager

Lead Gardener

Engineering Manager

Construction Planner

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